Nashville-based Webb Diagnostic Technologies has developed an antibody test its officials say can detect the presence of COVID-19 in a person with up to 99 percent accuracy in under one minute — a potential stand-out product in a market currently thwarted by unreliable technology and fraud.
Antibody tests currently on the market have been inaccurate, and very few have been approved by the Food and Drug Administration. These low-quality tests were developed to flood a market optimistic about its use, as the diagnostic tool took over headlines as the saving grace of testing that could identify asymptomatic patients and individuals possibly immune, as well as identify candidates for plasma donations for antibody-based treatments.
But uncertainty surrounding COVID-19 makes it hard to know how to apply tests like these to the current pandemic, according to Tennessee Department of Health Commissioner Lisa Piercey. Factors like reinfection — if someone who has COVID-19 antibodies present in their blood can contract the disease again — are still unknown.
“It’s almost been the Wild West in many ways, with people just throwing their products on the market without having much basis or scientific understanding," Webb Chief Technology Officer Kevin Jones told the Post.
Webb’s new device looks to change that. With feedback from industry leaders and a research-backed antibody search function, Jones said preliminary research showed the company's test can identify COVID-19 proteins in the blood with 99 percent accuracy at the point of care.
The device is a small contraption that can fit in the palm of your hand and requires a finger prick of blood to process results. It does not use specialized lab equipment or invasive procedures, but does need to be used by medical professionals and could not be deployed for at-home use.
The test is designed as a “total antibody test,” meaning it can detect all human immunoglobulins present in a patient’s blood if they are infected with COVID-19. As opposed to current tests on the market, which detect the presence of only a few. The broader view at human antibodies allows for a much higher success rate in detecting the virus, a task the Webb test can do in a much shorter amount of time, according to Jones.
“That is why you are seeing all the reports about serology tests not working and poor results […] even some of the best performing products will give you the wrong answer 10 percent of the time. It’s just a feature of using certain immunoglobulins,” Jones said. “We might get the wrong answer one percent of the time. Nothing is perfect; you are never going to be able to get a 100 percent accurate test. There is nothing out there that can do that. But obviously there is a big difference between one percent and 10 percent.”
Webb transitioned in early January to developing the antibody test after two years of designing a sepsis product to identify antibiotic overuse and effectiveness. Jones said that project was put on hold to address the growing issues surrounding COVID-19, and turnaround for the antibody test was easier because the technology had already been developed. The company simply needed virus samples to determine what it was looking for. That ended up being the hardest part.
At the early impact of the virus, Jones said a “fractured” national response delayed Webb's ability to obtain specimens needed to properly develop the test. Hospitals and labs weren’t collecting samples for research as they scrambled to save lives and identify new cases. Proper paperwork wasn’t in place to release patient specimens to research without consent, delaying Webb’s development by weeks.
“In the early stages, there were a lot of assumptions made about the right way to do this, about the way it was going to be done, about what is happening, and maybe that caused some hold-ups” Jones said. “I know we couldn’t get samples when we needed them, and that could have made a difference.”
Webb used eight partner companies to outsource production, manufacturing and distribution of the test. Nova Scotia-based MedMira's rapid-testing technology used for HIV, hepatitis and syphilis was tapped to develop the COVID-19 antibody test, which it will market as REVEALCOVID-19.
Jones said the company has filed an initial notice with the FDA and can now bring the test onto the market. In the coming days, Webb will submit its full application to the agency for approval.